我国药用辅料关联审评制度改革进展及思考

Progress and Considerations on the Reform of the Pharmaceutical Excipient Joint Review in China

目的:对比研究我国药用辅料关联审评制度与美国药品主文件登记制度的核心要素,为完善我国药用辅料管理制度提出几点建议。方法:对我国药用辅料关联审评制度和美国药品主文件登记制度涉及的登记范围、登记主体、登记资料要求,以及完整性审查、关联审评、变更管理6个核心要素做了对比研究。结果与结论:我国药用辅料关联审评制度的核心要素与美国药品主文件登记制度基本一致,但我国药用辅料管理在一些理念和实践层面均有进一步完善的空间,包括以风险为基础的管理理念有待深入贯彻,登记状态的意义有待进一步澄清,辅料的变更管理可进一步优化。

Objective:To propose several suggestions for improving China's pharmaceutical excipient management system by comparing the core elements of China's pharmaceutical excipient joint review and the Drug Master File system in the United States.Methods:A comparative study was made on the six core elements of China's pharmaceutical excipient joint review system and the US DMF registration,including registration scope,registration subject,registration data requirements,integrity review,joint review,and change management.Results and Conclusion:The core elements of China's pharmaceutical excipient joint review system were basically consistent with the US DMF registration system.However,it is not diffi cult to fi nd that there is room for further improvement in the management of pharmaceutical excipient in China at some conceptual and practical levels,including the risk-based management concept that needs to be further implemented,the signifi cance of registration status needs to be further clarified,and the change management of excipients that can be further optimized.